Search
Favorite Blogs
The Patent-Ineligibility trend continues to be infectious…
| October 29, 2018
Roche Molecular Systems, Inc. v. Cepheid
October 9, 2018
Before O’Malley, Reyna and Hughes. Opinion by Reyna. Concurring opinion by O’Malley.
Summary:
The contended patent, U.S. Patent No. 5,643,723 (‘723 patent), owned by Roche is directed to methods for detecting the pathogenic bacterium Mycobacterium tuberculosis (MTB). Prior to the priority date, the general methods of detection were slow (could take three to eight weeks), and they had limitations in that they could not identify if a patient has an antibiotic-resistant strain. The standard of care at the time was treatment with the antibiotic rifampin. However, outbreaks resulted due to delays in diagnosing and reporting of the rifampin-resistant tuberculosis. In 1994, rpoB became a prime candidate for studying rifampin resistance in MTB.
The inventors of the ‘723 patent sequenced the rpoB gene in MTB and discovered that that the rpoB gene in MTB contains eleven “position-specific” “signature nucleotides” (i.e., naturally occurring single nucleotide mutations) that are only present in MTB but not in other bacteria. Based on these eleven MTB-specific signature nucleotides, the Roche inventors devised a diagnostic test that could (1) identify whether or not a biological sample contains MTB, and (2) if MTB is present, predict whether that MTB is a strain that is resistant to rifampin treatment.
Subscribe | 登録
Archives
Tags
- “DuPont Factors” Test
- § 101
- § 271(a)
- §101
- §102
- §102(b)
- §103
- §112
- §112 sixth paragraph
- §120
- §251
- §271(f)(1)
- §271(f)(2)
- §284
- §292
- 101
- 102(g)
- 112 6th paragraph
- 112 sixth paragraph
- 112(f)
- 15 U.S.C. § 1052(a)
- 15 U.S.C. § 1117(a)
- 15 U.S.C. Section 1052(f)
- 271(e)
- 28 U.S.C. §1391
- 28 U.S.C. §1400
- 35 U.S.C. § 101
- 35 U.S.C. § 102(b)
- 35 U.S.C. § 112
- 35 U.S.C. § 251
- 35 U.S.C. § 285
- 35 U.S.C. § 315(c)
- 35 U.S.C. §100
- 35 U.S.C. §101
- 35 U.S.C. §102
- 35 U.S.C. §103
- 35 U.S.C. §112
- 35 U.S.C. §120
- 35 U.S.C. §145
- 35 U.S.C. §284
- 35 U.S.C. §285
- 35 U.S.C. §314(d)
- 35 U.S.C. §315(b)
- 35 U.S.C. 112 ¶ 1
- 35 U.S.C. 112 ¶ 2
- 35 U.S.C. 156
- 35 U.S.C. Section 101
- 35 USC 314(d)
- 35 USC 324(e)
- A-delay
- abandoned
- abandoned suppressed or concealed
- abandonment
- abstract
- abstract idea
- abstract ideas
- abuse of discretion
- accounting
- acquired distinctiveness
- administrative patent judge
- Administrative Procedure Act
- affidavit
- Agreement to Agreement
- AIA
- algorithm
- Alice
- Alice Corp.
- all elements rule
- amendments
- America Invents Act
- amount
- Analogous Art
- ANDA
- ANDA litigation
- antecedent basis
- anticipation
- antitrust
- app
- apparatus
- appeal
- appeal of decision whether to institute IPR
- appointment clause
- arbitration
- Aristocrat
- article of manufacture
- artificial intelligence
- assignment
- assignment in writing requirement
- attorney fees
- Attorneys’ Fees
- automated process
- basic and novel properties
- basic knowledge
- best mode
- bifurcated infringement
- bilski
- biotech
- BPAI
- BRI
- Broadening
- broadening reissue
- broadest reasonable interpretation
- burden of persuasion
- burden of proof
- Burden Shifting
- business method
- but-for test
- cancellation
- capable of
- case or controversy
- Causal Nexus
- CBM
- cDNA
- certificate of correction
- claim
- claim amendments
- claim broadening
- claim charts
- Claim Construcrtion
- claim construction
- Claim Construction during IPR
- claim context
- claim differentiation
- claim interpretation
- Claim Preclusion
- claim scope
- claims as originally filed
- claims construction
- claims drafting
- claims limited by title and specification
- clear and convincing standard
- clear error
- clinical trial
- close
- CLS Bank
- co-inventors
- Collateral Estoppel
- colorable-differences
- commercial exploitation
- commercial success
- common assignees
- common knowledge
- common ownership
- common sense
- comparative results
- computer
- computer aided method
- computer memory
- computer patents
- computer product
- computer system
- computer-implemented means-plus-function
- concealed
- concealment
- conception
- confidential use
- confidentiality
- confidentiality agreement
- consisting essentially of
- Constitutional Law
- contempt
- context
- continuation
- continuation application
- continuation-in-part
- Continuation-in-part-application
- contract
- contributory infringement
- control
- conversion of units or parameters
- Covered Business Method
- Covered Business Method (CBM)
- Covered Business Method (CBM) Patent Review
- CPU
- critical date
- critical range
- criticality of ranges
- cross-appeal
- DABUS
- damage
- damages
- Data Manipulation
- de novo
- de novo review
- declaration
- declaration and affidavit
- Declaratory judgment
- definiteness
- Delay due to regulatory review
- design
- Design Patent
- design patents
- diagnostic methods
- diagnostics
- Dilution
- direct infringement
- disavowal
- Disavowal of Claim Scope
- disclaimer
- disclosure-dedication doctrine
- divided infringement
- divisional
- divisional application
- DJ Jurisdiction
- DNA
- doctrine of equivalent
- doctrine of equivalents
- domestic benefit
- domestic industry
- double patenting
- drawings
- Due process
- Earliest effective date
- effective filing date
- egregious conduct
- election of species
- eligibility
- eligible subject matter
- employee
- employee testimony
- employment contract
- en banc
- enablement
- enabling disclosure; burden of proof
- enhanced damages
- entire market value
- entire market value rule
- Equitable estoppel
- Error Without Deceptive Intent
- estoppel
- evidence
- evidence of secondary considerations
- evidence to overcome presumption of enablement
- exceptional case
- Exceptional Cases
- exclusion of embodiment
- experimental use
- expert declaration
- expert declarations
- expert testimony
- expert witness
- expert witness fees
- Expiration
- expired patent
- extraterritoriality
- extrinsic evidence
- extrinsic vs. intrinsic evidence
- False marking
- FDA
- FDA regulatory review
- figure
- filing date
- financial
- First Amendment
- first-to-file
- first-to-invent
- Foreign Priority
- forfeiture
- fraud
- FRCP 60(b)(3)
- functional aspect
- functional claim language
- functional claim limitations
- functional claiming
- functional language
- functional limitation
- Functional method claim
- Functionality
- galaxy nexus
- general industry skepticism
- General Knowledge
- Generics
- genus
- genus-species
- geographical indication
- geographically misdescriptive
- good-faith
- hardware
- hatch-waxman
- hybrid claiming
- IDS
- Incorporation by reference
- incorportion
- indefiniteness
- indefiniteness; claim construction; standard of review
- indirect infringement
- indispensable party
- induced inf
- induced infringement
- inducement
- ineligible subject matter
- inequitable conduct
- information disclosure statement
- information disclosure statement (IDS)
- infringement
- Infringement under the Doctrine of Equivalents
- Inherency
- injunction
- injunctions
- institution
- intended purpose
- intended use
- intent
- Intent of Parties
- intent to deceive
- Intentional Surrender
- Inter Partes Reexamination
- inter partes review
- interference
- International Trade Commission (“ITC”)
- internet
- interpretation
- interpretation of a reference
- intervening rights
- intrinsic evidence
- invalidity
- inventive concept
- Inventor's agreements
- inventorship
- inventorship correction
- IPR
- irreparable harm
- issuance date
- Issue Preclusion
- JMOL
- Joinder
- joint inventors
- joint inventorship
- joint/divided infringement
- judgment on the pleadings under FRCP 12(c)
- jurisdiction
- Kessler Doctrine
- known in the art
- KSR
- laboratory technique
- laches
- Lanham Act Section 2(a)
- law of nature
- law-of-the case doctrine
- laws of nature
- lead compound
- legal fees
- lexicographer
- license
- licensee
- licensing
- licensing agreement
- light-emitting diodes
- Likelihood of Confusion under 15 U.S.C. § 1052(d)
- likelihood of success
- literal infringement
- makes
- malpractice
- mandate rule
- marking
- markush group
- materiality
- maternal serum or blood
- mathematical formula
- Mayo
- Mayo test
- Mayo/Alice Test
- Mean-Plus-Function
- means
- Means for
- means plus function
- means-plus function
- means-plus-function
- mental process
- method
- method claims
- misrepresentation of prior art knowledge
- mistake
- mobile app
- modification
- molecular weight
- motion to amend
- Motion to Dismiss
- Motion to Stay
- Motion to Submit supplemental information
- Motivation
- motivation to combine
- MPF
- multiple embodiments
- Myriad
- Narrowing
- natural law
- NDA
- negative limitation
- New Ground of Rejection
- new matter
- nexus
- non practicing entities
- non-disclosure agreement
- non-enablement
- non-enabling prior art
- non-infringement opinion
- non-patent literature
- notice
- Notice and Opportunity to Respond
- novelty
- npe
- nucleotide
- objective indicia of nonobviousness
- objective recklessness
- obvious to try
- obviousness
- Obviousness of ranges
- obviousness-type double patenting
- offers to sell
- office action
- Official Notice
- on sale bar
- ongoing royalty
- online periodical
- open-ended claim range
- operability
- or sells; within the United States.”
- ordinary and
- ordinary and customary meaning
- ordinary meaning
- original patent requirement
- overlap
- own lexicographer
- ownership
- parallel litigation
- patent eligibility
- patent eligible subject matter
- patent exhaustion
- patent ineligible
- patent ineligible abstract idea
- patent ineligible subject matter
- patent infringement
- patent invalidation
- patent invalidity
- patent marking
- patent ownership
- patent term
- Patent Term Adjustment
- Patent Term Adjustment (PTA)
- Patent Term Extension
- Patent Trial and Appeal Board (PTAB)
- patent venue
- patent-eligible subject matter
- patentability
- patentable subject matter
- PCT application
- permanent injunction
- personal jurisdiction
- personalized treatment methods
- Petition
- Petitioner's burden in IPR
- physical phenomena
- possession
- Post Grant Review
- pre-AIA
- preamble
- preamble-within-a-preamble
- predictable
- preemption
- prejudice
- prejudicial treatment
- preliminary injunction
- prenatal diagnosis
- preparation
- preponderance of evidence
- presumption of enablement
- presumption of validity
- prima facie case of obviousness
- Primary Reference
- principle operation
- printed publication
- printed publications
- prior art
- prior inventor
- priority
- Problem to be Solved
- procedural issues
- process
- Process Conditions
- process limitation
- processor
- product of nature
- product-by- process claim
- product-by-pass claims
- product-by-process claims
- prosecution argument
- prosecution disclaimer
- prosecution history
- prosecution history disclaimer
- prosecution history estoppel
- prototype
- provisional
- PTA
- PTA reduction
- PTAB's sua sponte claim construction
- PTE
- PTO Litigation
- public access
- public accessibility
- public availability
- public use
- public use bar
- Publicly available as prior art
- qualitative meaning
- quantitative meaning
- qui tam actions
- range
- ranges
- RCE
- re-examination
- real party in interest
- Reason to combine
- reasonable certainty
- Reasonable Expectation of Success
- reasonable royalty
- recapture
- reduction to practice
- reexamination
- regular and established place of business
- reissue
- Reissue application
- Reissue Claim
- Reissue patent
- Request for Continued Examination
- res judicata
- restriction
- restriction requirement
- Result Effective Variable
- retroactive laws
- right to repair
- royalty
- Rule 19
- rule 4(k)(2)
- rule 60(b)
- Rule of Reason
- safe harbor
- safe harbor rule
- sanctions
- scanner
- Seagate
- secondary considerations
- secondary meaning
- secret use
- Section 101
- section 1400(b)
- Section 2(f) of the Lanham Act
- Section 337
- Self-enabling
- sequence
- significantly more
- Similarity of Marks
- Skilled Artisan
- smartphone
- smoke generating device
- SNQ
- software
- software patent
- software patents
- sovereign immunity
- species
- specific intent
- specification
- specification drafting
- specification examples
- Specimen of Use
- standard of proof
- standard of review
- Standing
- standing to appeal
- standing to appeal IPR decision
- statute of limitations
- statutory estoppel
- strong presumption
- structural limitation
- Subject Matter Eligibility
- Subject Matter Eligibility; § 101
- subject matter jurisdiction
- Substantial evidence
- substantial new question of patentability
- substantial non-infringing use
- substitute claim
- substitution of known elements
- summary judgment
- superfluous
- Supplemental Examination
- supplier exeption
- suppressed
- Supreme Court
- surrender
- tangential exception
- tangential relation
- Teach Away
- teaching away
- technological improvement
- terminal disclaimer
- the Binary Limitation of the Doctrine
- The Supreme Court
- third party use
- Tho
- ThomasBrown
- time-bar
- Time-bar and Privity under § 315(b)
- title
- trade dress
- trade secret
- trade secret misappropriation
- Trademark
- translation
- treatment
- treatment method
- two-year window
- Type A delay
- Type B delay
- Type C delay
- unexpected data
- unexpected result
- unexpected results
- unforseeability
- use in trade
- uses
- utility patent
- validity
- venue
- vitiation
- waiver
- willful blindness
- willful infringement
- willfulness
- writ of mandamus
- written description
- written description requirement
